Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
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First Received Date ICMJE | June 28, 2012 | ||||
Last Updated Date | September 27, 2012 | ||||
Start Date ICMJE | September 2012 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Esophageal Stricture [ Time Frame: 6 to 8 Weeks ] [ Designated as safety issue: Yes ] Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope). |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01633411 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium | ||||
Official Title ICMJE | Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium | ||||
Brief Summary | This is a feasibility study without a primary study hypothesis or statistical comparison. |
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Detailed Description | The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken. Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following:
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Barrett's Esophagus | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. Epub 2011 Apr 30. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | December 2013 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Netherlands | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01633411 | ||||
Other Study ID Numbers ICMJE | CP-0003.A | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | C2 Therapeutics, Inc. | ||||
Study Sponsor ICMJE | C2 Therapeutics, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | C2 Therapeutics, Inc. | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |